FDA 510(k) Application Details - K131881

Device Classification Name Compressor, Air, Portable

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510(K) Number K131881
Device Name Compressor, Air, Portable
Applicant TRUDELL MEDICAL INTL.
725 THIRD ST.
LONDON N5V 5G4 CA
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Contact DARRYL FISCHER
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Regulation Number 868.6250

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Classification Product Code BTI
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Date Received 06/25/2013
Decision Date 10/24/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K131881


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